Pharmacovigilance 2.0

• Purpose: To detect, quantify, contextualize, and ultimately prevent medication-related harm

• Primary research question: What adverse drug events are associated with commonly used medications among Medicare beneficiaries?

• Innovative methodology:

  • Real World Data Integration: Transitioning from the inherent biases of voluntary or “spontaneous” adverse drug event (ADE) reporting systems, Pharmacovigilance 2.0’s integration of comprehensive real world data (RWD) captures critical details pertaining to medication exposure, reveals unreported ADEs, and includes detailed patient narratives. This novel utilization of RWD signifies a sea change in safeguarding public health.

  • Surveillance Amplified: A departure from passive safety signal surveillance, Pharmacovigilance 2.0 actively detects medication-related safety signals exposing otherwise concealed patient harm using systematic and innovative methods.

  • Contextual Understanding: Elevating from isolated safety signals devoid of context, Pharmacovigilance 2.0 employs rigorous methodology to identify, contextualize, and confirm adverse drug events thereby generating robust inferences regarding medication related harm.

Results